Search Results
Found 2 results
510(k) Data Aggregation
(17 days)
DigitalDiagnost C50
The DigitalDiagnost C50 system is intended for use in generating radiographic images of human anatomy by qualified/ trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The DigitalDiagnost C50 Digital Radiography System (DigitalDiagnost C50) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients. The DigitalDiagnost C50 consist of the following components: ceiling suspension with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and an acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.
Here's a breakdown of the acceptance criteria and study information for the DigitalDiagnost C50, based on the provided text.
1. Table of Acceptance Criteria & Reported Device Performance:
| Feature | Acceptance Criteria (Predicate) | Reported Device Performance (DigitalDiagnost C50) | Comment on Equivalence |
|---|---|---|---|
| Basic information | |||
| Product Code | KPR | Identical (KPR) | No difference; thus, demonstrating SE. |
| Regulation No. | 21 CFR 892.1680 | Identical (21 CFR 892.1680) | No difference; thus, demonstrating SE. |
| Device Class | II | Identical (Class II) | No difference; thus, demonstrating SE. |
| Electrical Requirement | Input voltage: 3-phase, 200/208/240/380/400/415/440/480/500Vac; Frequency:50/60Hz; Current: Short term: 112A (with generator M-CABINET CXA 50kW), 134A (M-CABINET CXA 65kW); Long term: 10A. | Identical | No difference; thus, demonstrating SE. |
| Design characteristic | |||
| X-ray Tube | RO 1750 ROT 380 & SRO 33100 ROT 380 | Identical | No difference; thus, demonstrating SE. |
| Max Tube Voltage | 150 kV | Identical | No difference; thus, demonstrating SE. |
| Focal Spot Size | 0.6mm/1.2mm | Identical | No difference; thus, demonstrating SE. |
| Tube Max power | 50KW/100KW (250W equivalent anode input power) | Identical | No difference; thus, demonstrating SE. |
| Anode Type | Rotation | Identical | No difference; thus, demonstrating SE. |
| Generator | Philips Healthcare (Suzhou), M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW | Identical | No difference; thus, demonstrating SE. |
| Max Power | 50KW/65KW | Identical | No difference; thus, demonstrating SE. |
| KV range | 40-150 | Identical | No difference; thus, demonstrating SE. |
| Milli ampere sec (mAs) product | 0.4 mAs-600 mAs (with AEC control) | Identical | No difference; thus, demonstrating SE. |
| Collimator | |||
| Operation Mode | Manual collimation | Identical | No difference; thus, demonstrating SE. |
| Shape of Beam | Rectangular | Identical | No difference; thus, demonstrating SE. |
| Detector | |||
| Type | Digital Detector, Fixed RAD Detector, Wireless Static Detector | Identical | No difference; thus, demonstrating SE. |
| Fixed RAD Detector | Pixium 4343RG | Pixium 4343RCE (identical to predicate DigitalDiagnost C90 K182973) | The difference between 4343RCE and 4343RG is scintillator material and other minor differences of image area and image matrix. The differences don't affect the safety or effectiveness. Thus, demonstrating SE. |
| Wireless Static Detector | Varian PaxScan4336W | SkyPlate E (Trixell 3543DR) (identical to reference MobileDiagnost WDR 2.2 K191813) | The Skyplate E Detector is identical to the Skyplate E Detector of the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019). Thus, demonstrating SE. |
| X-ray Scintillator Material (Fixed) | GdOS (Fixed: Pixium 4343RG) | Cesium Iodide (Fixed: Pixium 4343RCE) | The fixed RAD detector of the proposed DigitalDiagnost C50 and currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC) are both fabricated from identical Cesium Iodide material, thus demonstrating SE. |
| X-ray Scintillator Material (Wireless) | GdOS (Wireless Varian PaxScan4336W) | Cesium Iodide (Wireless SkyPlate E) | The Wireless Detector of the proposed DigitalDiagnost C50 and the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019) are both fabricated from identical Cesium Iodide material, thus demonstrating SE. |
| Image Area (Fixed) | 42.5cm x 42.5cm (Fixed: Pixium 4343RG) | 42.03cm x 42.54cm (Fixed: Pixium 4343RCE) | The image area of the DigitalDiagnost C50, provided with fixed RAD detector is identical to the image area of the Fixed RAD Detector of the currently marketed and Reference Device 3, DigitalDiagnost C90(K182973- January 11, 2019, Philips Medical Systems DMC), thus demonstrating substantial equivalence. |
| Image Area (Wireless) | 42.7 cm x 34.4 cm (Wireless: Varian PaxScan4336W) | 34.5 cm x 42.5cm (Wireless: SkyPlate E) | The image area of the proposed Wireless Detector SkyPlate E is identical to the Wireless Detector SkyPlate E of the currently marketed and reference device 1, MobileDiagnost WDR 2.2 (K191813- August 2, 2019, Sedecal SA). thus demonstrating SE. |
| Image Matrix (Fixed) | 2,874 x 2,869 (Fixed: Pixium 4343RG) | 2,874 x 2840 (Fixed: Pixium 4343RCE) | The image matrix of the proposed DigitalDiagnost C50, provided with fixed RAD detector is similar to the image matrix of the currently marketed and Reference Device 3, DigitalDiagnost C90. Thus demonstrating substantial equivalence. Infinitesimal change in the image size (X-ray field) does not impact clinical Image Quality. Therefore, they are equivalent and there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
| Image Matrix (Wireless) | 3,072 x 2,476 (Wireless: Varian PaxScan4336W) | 2,156 x 2,653 (Wireless-SkyPlate E) | The image matrix of the proposed DigtialDiagnost C50 provided with wireless detector SkyPlate E is similar to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2. Infinitesimal change in the image size (X-ray field) does not impact clinical Image Quality. Therefore, they are equivalent and there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
| Pixel Size (Fixed) | 148 μm (Fixed: Pixium 4343RG) | 148 μm (Fixed: Pixium 4343RCE) | The pixel size of the proposed DigtialDiagnost C50 provided with fixed RAD detector is identical to the pixel size of the currently marketed and Reference Device 3, DigitalDiagnost C90. Thus demonstrating substantial equivalence. |
| Pixel Size (Wireless) | 139 μm (Wireless: Varian PaxScan4336W) | 160 μm (Wireless-SkyPlate E) | The pixel size of the proposed DigtialDiagnost C50 provided with wireless detector SkyPlate E is identical to the currently marketed and Reference Device 1, MobileDiagnost WDR 2.2. Thus demonstrating SE. |
| Analog / Digital (A/D) conversion | 16 bits | Identical | No difference; thus, demonstrating SE. |
| Table | |||
| Table type | Fixed and Height adjustment | Identical | No difference; thus, demonstrating SE. |
| Height adjustment | 51.5 cm to 91.5 cm above floor, motorized adjustment | Identical | No difference; thus, demonstrating SE. |
| Tabletop longitudinal travel range | +/- 550mm | Identical | No difference; thus, demonstrating SE. |
| Tabletop Lateral travel | +/- 130mm | Identical | No difference; thus, demonstrating SE. |
| Loading (patient weight) | 210 Kg | Identical | No difference; thus, demonstrating SE. |
| Wall Stand | |||
| Vertical movement range | 1500mm | Identical | No difference; thus, demonstrating SE. |
| Movement mode | Manual | Identical | No difference; thus, demonstrating SE. |
| Tube Stand | |||
| Type | Ceiling suspension | Identical | No difference; thus, demonstrating SE. |
| Tube rotation | +/- 135 degree | Identical | No difference; thus, demonstrating SE. |
| Longitudinal movement range | 1500 mm | Identical | No difference; thus, demonstrating SE. |
| Source to Image Distance (SID) | |||
| SID | SID depends on different configurations, because the DigitalDiagnost C50 is a ceiling suspension X-ray system. | Identical | No difference; thus, demonstrating SE. |
| External Connectivity | |||
| DICOM | DICOM 3.0 compatible | Identical | No difference; thus, demonstrating SE. |
| Software Platform | |||
| Software | Eleva WorkSpot | Identical | No difference; thus, demonstrating SE. |
| SkyFlow Software | No | Yes | The proposed Digital Diagnost C50 includes the SkyFlow software used in the currently marketed and reference device Eleva Workspot with SkyFlow, (K153318- December 22, 2015, Philips Medical Systems DMC), thus, demonstrating SE. |
| Image Processing Algorithm | UNIQUE | UNIQUE 2 | UNIQUE 2 image processing algorithm provided with DigitalDiagnost C50 was previously cleared with the currently marketed and Reference Device 3, DigitalDiagnost C90 (K182973- January 11, 2019, Philips Medical Systems DMC). Upgrading to UNIQUE2 image processing algorithm does not alter the clinical workflow, hence no impact on the safety or effectiveness of the device; thus, demonstrating SE. |
| Operating System | Windows 7 embedded | Windows 10 embedded | Introduction of operating system Windows 10 embedded does not impact clinical image quality. Therefore, there is no impact on the safety and effectiveness of the device; thus, demonstrating SE. |
Study Proving Acceptance Criteria:
The document states that a non-clinical verification/validation study was performed. The basis for substantial equivalence is that the DigitalDiagnost C50 is considered equivalent to the predicate DigitalDiagnost C50 (K163410) based on:
- Identical Indications for Use.
- Fundamental scientific technology (including largely identical components or components identical to other cleared reference devices).
- Non-clinical performance testing (demonstrating compliance with standards).
- Safety and effectiveness (as supported by the non-clinical testing).
The non-clinical verification and validation tests demonstrated that the DigitalDiagnost C50:
- Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance documents.
- Meets the acceptance criteria and is adequate for its intended use.
2. Sample size used for the test set and the data provenance:
The document explicitly states: "The DigitalDiagnost C50 does not require clinical study..." and "Summary of Clinical Data: Based on the information provided above, the DigitalDiagnost C50 is considered substantially equivalent to the currently marketed and predicate DigitalDiagnost C50 (K163410, January 4, 2017) in terms of fundamental scientific technology."
Therefore, there appears to be no clinical test set, sample size, or specific data provenance for a clinical study as part of this 510(k) submission. The evaluation relies on non-clinical performance data and equivalence to predicate/reference devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical study with a test set was performed, this information is not applicable and not provided in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Since no clinical study with a test set was performed, this information is not applicable and not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was mentioned. The device described, DigitalDiagnost C50, is an X-ray system, not an AI-assisted diagnostic device. Therefore, this information is not applicable and not provided in the document.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The DigitalDiagnost C50 is an X-ray imaging system. There is no mention of a standalone algorithm-only performance study, as it's not a standalone diagnostic algorithm. Therefore, this information is not applicable and not provided in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical verification and validation tests, the "acceptance criteria" were derived from international and FDA-recognized consensus standards and FDA guidance documents (listed on pages 11-12). These standards themselves implicitly define the "ground truth" or acceptable performance ranges for device characteristics, image quality, electrical safety, radiation protection, software lifecycle, usability, and risk management. No other forms of expert consensus, pathology, or outcomes data are mentioned for establishing ground truth for the device's technical specifications.
8. The sample size for the training set:
Since no clinical study or AI algorithm training is described for this device, this information is not applicable and not provided in the document.
9. How the ground truth for the training set was established:
Since no clinical study or AI algorithm training is described for this device, this information is not applicable and not provided in the document.
Ask a specific question about this device
(30 days)
DigitalDiagnost C50
The DigitalDiagnost C50 system is intended for use in generating radiographic images of human anatomy by qualified/ trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.
The Philips DigitalDiagnost C50 Digital Radiography System (Philips DigitalDiagnost C50) is a flexible digital radiography (DR) system that is designed to provide fast and smooth radiography examinations of sitting, standing or lying patients.
The Philips DigitalDiagnost C50 consists of the following components: ceiling suspension with X-ray assembly, wall stand with detector carrier, patient table with detector carrier and floating table top, high voltage generator, and an acquisition and reviewing workstation for post-processing, storage and viewing of images. Images may be transferred via a DICOM network for printing, storage and detailed review.
Based on the provided text, the device in question, the Philips DigitalDiagnost C50, is a stationary x-ray system cleared through a 510(k) premarket notification. The document does not describe acceptance criteria or a study that proves the device meets acceptance criteria in the context of an AI/algorithm-driven diagnostic aid.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Philips DuraDiagnost K141381) and a reference device for the wireless detector (Varian Nexus DR™ Digital X-ray Imaging System K161459).
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets acceptance criteria related to AI/algorithm performance, a multi-reader multi-case study, standalone algorithm performance, or the ground truth establishment for a training set. The device is a traditional x-ray system, not an AI-powered diagnostic tool as suggested by some of the detailed questions.
However, I can extract information regarding overall device compliance and performance from the text as it relates to demonstrating substantial equivalence for an X-ray system:
Acceptance Criteria and Device Performance for the Philips DigitalDiagnost C50
The provided text on the Philips DigitalDiagnost C50's 510(k) submission does not include acceptance criteria and a study in the context of an AI-driven diagnostic device. Instead, it focuses on demonstrating substantial equivalence to predicate and reference devices for a stationary X-ray system. The "acceptance criteria" mentioned refer to the device meeting the requirements set forth by international and FDA-recognized consensus standards and device-specific guidance documents, as well as the successful completion of non-clinical verification and validation tests.
1. Table of Acceptance Criteria and Reported Device Performance (as related to Substantial Equivalence and Safety/Effectiveness):
The document details a comparison of technological characteristics between the proposed device (DigitalDiagnost C50) and its predicate (Philips DuraDiagnost) and reference device (Varian Nexus DR™ Digital X-ray Imaging System for the wireless detector). The "acceptance criteria" here are implicitly that the proposed device's characteristics are either identical or that any minor differences do not affect the safety or effectiveness, thus demonstrating substantial equivalence (SE).
| Feature | Acceptance Criteria (based on Predicate/Reference Device Equivalence) | Reported Device Performance (Philips DigitalDiagnost C50) |
|---|---|---|
| X-ray Tube | Similar x-ray tubes, with identical specifications for nominal X-ray tube voltage, nominal focal spot values, maximum tube current, maximum anode heat content, total filtration, maximum and anode heat dissipation. Minor difference in tube housing should not affect performance, safety, and effectiveness. | Uses RO 1750 ROT 380 & SRO 33100 ROT 380, which are similar and have the same specifications as the predicate's tubes (RO 1750 ROT 360 & SRO 33100 ROT 360). The minor tube housing difference has no impact on safety and effectiveness, demonstrating SE. |
| Max Tube Voltage | Same as predicate (150kV). | Same (150kV). No difference; demonstrating SE. |
| Focal Spot Size | Same as predicate (0.6mm/1.2mm). | Same (0.6mm/1.2mm). No difference; demonstrating SE. |
| Tube Max Power | Same as predicate (50KW/100KW, 250W equivalent anode input power). | Same (50KW/100KW, 250W equivalent anode input power). No difference; demonstrating SE. |
| Anode Type | Same as predicate (Rotation). | Same (Rotation). No difference; demonstrating SE. |
| Generator | Equivalent to predicate (M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW, M-CABINET Pro CXA 80kW, particularly 50kW/65kW). Minor difference in max power (80kW not included) should not affect safety and effectiveness. | Uses M-CABINET CXA Pro 50kW, M-CABINET CXA Pro 65kW. Max Power 50KW/65KW. These are equivalent to the predicate's available generators, with no impact on safety and effectiveness, demonstrating SE. |
| kV range | Same as predicate (40-150). | Same (40-150). No difference; demonstrating SE. |
| Milliampere second (mAs) product | Same as predicate (0.4 mAs-600 mAs with AEC control). | Same (0.4 mAs-600 mAs with AEC control). No difference; demonstrating SE. |
| Collimator Operation Mode | Same as predicate (Manual collimation). | Same (Manual collimation). No difference; demonstrating SE. |
| Shape of Beam | Same as predicate (Rectangular). | Same (Rectangular). No difference; demonstrating SE. |
| Detector Type | Fixed: Identical to predicate (GdOS). Wireless: Identical to reference device (PaxScan 4336Wv4 in Varian Nexus DR™ Digital X-ray Imaging System). No impact on safety and effectiveness. | Fixed: GdOS (identical to predicate). Wireless: PaxScan 4336Wv4 (GdOS), identical to the reference device. No impact on safety and effectiveness, demonstrating SE. |
| X-ray Scintillator Material | Fixed: Identical to predicate (GdOS). Wireless: Identical to reference device (GdOS) which replaces the predicate's Cesium Iodide. No impact on safety and effectiveness. | Fixed: GdOS (identical to predicate). Wireless: GdOS (identical to the reference device). No impact on safety and effectiveness, demonstrating SE. |
| Image Area | Fixed: Identical to predicate (42.5cm x 42.5cm). Wireless: Functionally equivalent/identical to reference device (42.7 cm x 34.4 cm vs. reference 42.4cm x 34.8cm). Minor differences should not impact safety and effectiveness. | Fixed: 42.5cm x 42.5cm (identical to predicate). Wireless: 42.7 cm x 34.4 cm (functionally equivalent to reference device's 42.4cm x 34.8cm). No impact on safety and effectiveness, demonstrating SE. |
| Image Matrix | Fixed: Identical to predicate (2874 x 2869). Wireless: Functionally equivalent/identical to reference device (3072 x 2476 vs. reference 2866 x 2350). Minor differences should not impact safety and effectiveness. | Fixed: 2874 x 2869 (identical to predicate). Wireless: 3072 x 2476 (functionally equivalent to reference device's 2866 x 2350). No impact on safety and effectiveness, demonstrating SE. |
| Analog / Digital (A/D) conversion | Same as predicate (16 bits). | Same (16 bits). No difference; demonstrating SE. |
| Source to Image Distance (SID) | Minor differences are acceptable as long as they do not alter application usage and are supported by bench testing results. | SID depends on configurations (ceiling suspension system). Slight difference compared to predicate (Table: 40-115cm; Wallstand: 110-245cm) but bench testing (Section 17) proved no alteration to application usage; thus, no impact on safety and effectiveness, demonstrating SE. |
| External Connectivity | Same as predicate (DICOM 3.0 compatible). | Same (DICOM 3.0 compatible). No difference; demonstrating SE. |
| Software Platform | Same as predicate (Eleva workspot). | Same (Eleva workspot). No difference; demonstrating SE. |
| Compliance with Standards | Complies with specified international and FDA-recognized consensus standards and device-specific guidance documents (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, IEC 62304, ISO 14971, IEC 62366, CFR 1020.30, CFR 1020.31, FDA guidance documents). | Compliance confirmed through non-clinical verification and validation tests. The device "Meets the acceptance criteria and is adequate for its intended use" based on these tests. |
2. Sample Size and Data Provenance for Test Set (for an AI/Algorithm):
- Not applicable. The submission is for a traditional X-ray system, not an AI/algorithm-driven diagnostic device. The performance data relies on comparing the technical specifications and non-clinical bench testing against established standards and predicate devices.
3. Number of Experts and Qualifications to Establish Ground Truth (for an AI/Algorithm):
- Not applicable. See point 2.
4. Adjudication Method for Test Set (for an AI/Algorithm):
- Not applicable. See point 2.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. The document explicitly states: "The DigitalDiagnost C50 did not require a clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: Design features; Indication for use; Fundamental scientific technology; Non-clinical performance testing; and Safety and effectiveness." There is no mention of an MRMC study or an effect size for human readers with or without AI assistance.
6. Standalone Algorithm Performance:
- Not applicable. The device is an X-ray system, not a standalone algorithm.
7. Type of Ground Truth Used (for an AI/Algorithm):
- Not applicable. For this X-ray system, "ground truth" for performance is established through adherence to recognized standards, technical specifications, and successful non-clinical performance (bench) testing, demonstrating that the images generated are of appropriate quality and the system functions safely and effectively as intended.
8. Sample Size for the Training Set (for an AI/Algorithm):
- Not applicable. See point 2.
9. How the Ground Truth for the Training Set Was Established (for an AI/Algorithm):
- Not applicable. See point 2.
In summary, the Philips DigitalDiagnost C50 is a conventional X-ray system whose acceptance criteria are fundamentally tied to demonstrating substantial equivalence to legally marketed predicate devices through comprehensive non-clinical performance (verification and validation) tests and adherence to established international and FDA-recognized consensus standards. The document does not describe the evaluation of an AI or algorithm.
Ask a specific question about this device
Page 1 of 1